STATUS OF HEALTH TECHNOLOGY ASSESSMENT IN INDIA (2010)

Dr. SHOEB AHMED ILYAS, HTA REPORT IINDIA

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STATUS OF HEALTH TECHNOLOGY ASSESSMENT IN INDIA (2010)

Dr. Shoeb Ahmed

B.S, BDS, PGDHM, PGDMLE, PGDHA, EMSRHS, MPH, M.Sc. (Psy), MHRM, M.Sc.

(Biotech), F.H.T.A, MS (Global Health), M.Phil (HHSM), FRHS, FMSPI, DEM & ISO

14000/ 14001, Cert. in Health Economics (World Bank), CPHQ, (PhD).

Hospital and Health systems Management Consultant.

Health Technology Assessment Consultant.

Health Care Quality Management Consultant.

Ruby Med Plus M: +919666148506

Email: [email protected] / [email protected].

Begumpet,

Hyderabad-500016


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Introduction of Health Care Systems in India

Primary Care

It is the basic care available to the rural India by support centers like Primary Health Care Center

(PHC) and is the first contact point between village community and the Medical Officer. The

PHCs were envisaged to provide an integrated curative and preventive health care to the rural

population with emphasis on preventive and promotive aspects of health care. The PHCs are

established and maintained by the State Governments under the Minimum Needs Programme

(MNP)/ Basic Minimum Services Programme (BMS). At present, a PHC is manned by a Medical

Officer supported by 14 paramedical and other staff. It acts as a referral unit for 6 Sub Centers. It

has 4 - 6 beds for patients. The activities of PHC involve curative, preventive, primitive and

Family Welfare Services. There are 22,370 PHCs functioning as on March 2007 in the country.

(WHO REPORT- 2009)

Out & In-Patient Care Over the last decade, there has been a substantial increase in the

dependence on the private sector for outpatient and inpatient care. Though there is reduction in

the use of government facilities during the past decade, the poor and hilly states still depend

largely on government facilities for outpatient and inpatient care. For inpatient care, 45 percent

of the poor continue to depend upon public sector hospitals. Inadequate public health facilities

are such that less than 20 percent of the population which seeks OPD services and less than 45

percent of that which seeks hospitalization avail of Health services in public hospitals. This

reflects the imbalance in the development of the public health manpower and infrastructure in

India.


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Hospital Care

Over 75% of the human resources, 68% of an estimated 15,097 hospitals and 37% of 623,819

total beds in the country are in the private sector. (GO1, 2005) It is reported that there are 1369

hospitals with a bed capacity of over 53000 in India catering to the needs of traditional Indian

healthcare; about 726,000 registered practitioners are working under the traditional healthcare

system.

Average expense per hospitalization

Average expenses per hospitalization is Rs 3228 ($65) in public hospitals and Rs. 7408 ($150)

in private hospitals.

Productivity Loss

30% to 50% of productive time lost during illness varies by illness, severity of illness.

Table – 1 shows: Density of Health Workers in India

Categories Year

Number Density per 1000

Physicians 2005 645285 0.60

Nurses 2004 865135 0.80

Midwives 2004 506924 0.47

Dentists 2004 61424 0.06

Pharmacists 2003 592577 0.56

Public and Environmental 1991 325263 0.38

Health Workers

Community Health Workers 2004 50393 0.05

Lab Technicians 1991 15886 0.02

Other Health Workers 2005 818301 0.76

Source: working together for Health, World Health Report, 2006.


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Governance

Primary responsibility is of State government in association with collaboration with private

sector and NGO’s.

Figure -1 showing Frame work of Governance in India.

Act and Rules which help in Governance of Health Care Facilities in India

Health Facilities & Services

Disease Control & Medical Care

Human Resource

Ethics & Patients Rights

Pharmaceuticals & Medical Devices

Radiation Protection

Hazardous Substances

Occupational Health & Accident Prevention

Elderly, Disabled, Rehabilitation & Mental Health

Family, Women & Children

Smoking Alcoholism & Drug Abuse

Social Security & Health Insurance

Environmental Protection

Nutrition & Food Safety

Health Information & Statistics


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Intellectual Property Rights

Custody, Civil & Human Rights.

Health care financing In India

The imperative for opening of the insurance sector in India is due to signing of the WTO (World

Trade Organization) in India which opened the entire financial sector - including insurance

sector to private and foreign investors.

Health Care financing in India is by a number of sources: (I) the tax-based public sector that

comprises local, State and Central Governments, in addition to numerous autonomous public

sector bodies (ii) the private sector including the not-for-profit sector, organizing and financing,

directly or through insurance, the health care of their employees and target populations; (iii)

households through out-of-pocket expenditures, including user fees paid in public facilities; (iv)

other insurance-social and community-based; and (v) external financing (through grants and

loans).

Figure -2 : Share of entities in total health spending during 2001-02.

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Over the last 50 years India has achieved an assortment in terms of health improvement. But still

India is way behind many fast developing countries such as China, Vietnam and Sri Lanka in

terms of health indicators (Satia et al 1999). Public Financial support for healthcare has been

historically low in India, averaging less than 1 per cent of the GDP. Public financing of

healthcare comes largely from state government budgets, about 80 per cent, and the balance from

the Union government (12 per cent) and local governments (8 per cent). Of the total public

health budget today, about 10 per cent is externally financed. . The public health system caters to

20 per cent of ambulatory care, 45 per cent of hospitalizations, 50 per cent of institutional

deliveries, 65 per cent of antenatal care, 80 per cent of immunizations and 90 per cent of family

planning services. Both the central and state governments spend in the form of capital resource

allocations and revenue expenditure on the health sector.

India is the most privatized health market in the world as private health sector grew rapidly,

from being about 3 per cent of GDP in the beginning of 1990s to over 6 per cent today. In fact,

the overall health sector in India has been growing at the rate of 1.4 times that of the GDP. This

also means that the burden out-of-pocket on households is also increasing rapidly and more so

for the poorer sections, especially since the public health expenditures are declining. The total

value of the health sector in India today is more than Rs 1,500 billion or US$ 34 billion. This

works out to $34 per capita which is 6 per cent of GDP. Of this 15 per cent is publicly financed,

4 per cent is from social insurance, 1 per cent private insurance and the remaining 80 per cent

being out of pocket as user-fees (85 per cent of which goes to the private sector), hence India is

the most privatized health market in the world. Two thirds of the users are purely out-of-pocket

users and 90 per cent of them are from the poorest sections. (See- table-


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Figure -3 shows the broad channels or groups that incur monetary expenses on health and

medical cares.

Public expenditure consists of all the government expenditure on health and family welfare, at

the central and state government levels: on medical education, research, hospitals, Public Health

Centers (PHCs), Auxiliary Nurse Mid-wife (ANM) services and so on. This also includes, by

definition, the government expenditure as subsidy. Examples are, subsidy through Central

Government Health Scheme (CGHS), medical reimbursements etc.

Table -2 showing Pattern of Public

Expenditure on Health Care

Revenue Expenditure

Capital Expenditure

Year Central State Central State

As percent of As As percent of

As As percent of As As percent of As

Total Revenue percent Total Revenue percent Total Capital percent Total Capital percent

Expenditure of GDP Expenditure of GDP Expenditure of GDP Expenditure of GDP

1980-81 0.729 0.088 9.39 1.136 0.083 0.007


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Note: Data regarding health sector expenditure of the central government relate only to

developmental expenditure.

Source: RBI Bulletin and Currency and Finance various issues

It is important to note here that the share of public expenditure on health and medical care are

expressed in terms of (I) out of total public expenditure and (ii) as a ratio of the GDP. Which are

two important macroeconomic fiscal indicators. The per capita public expenditure allocation

however, is a useful indicator, but only in juxtaposition with per capita private expenditure. It

will then reflect the degree of privatization in the Indian economy.

Analysis of Private Expenditure in Health care Sector in India

There are two major sources of information for analysis of Public expenditure at the macro level,

the Central Statistical Organization (CSO) and the National Sample Surveys (NSS). Personal

expenditure from both the sources of data refers to the expenditure incurred by the people as

personal consumption expenditure. This may be either what they have paid out from their own

pockets or through some health insurance schemes. Expenditure on medical care, there is a

1981-82 0.788 0.087 9.862 1.176 0.109 0.009 0.312 0.019

1982-83 0.8 0.097 9.94 1.262 0.088 0.007 0.359 0.02

1983-84 0.756 0.093 11.302 1.301 0.013 0.001 0.492 0.022

1984-85 0.718 0.096 9.765 1.327 0.067 0.006 0.362 0.02

1985-86 0.602 0.09 9.846 1.38 0.027 0.002 0.371 0.019

1986-87 0.71 0.006 9.805 1.435 0 0 0.436 0.02

1987-88 0.582 0.095 9.621 1.481 0.102 0.006 0.417 0.021

1988-89 0.643 0.103 8.728 1.292 0.077 0.005 0.39 0.016

1989-90. 0.549 0.104 9.058 1.331 0.073 0.005 0.315 0.013

1990-91 0.643 0.103 8.672 1.303 0.006 0 0.306 0.012

1991-92 0.602 0.093 7.904 1.232 0.069 0.004 0.372 0.015

1992-93 0.647 0.099 8.062 1.23 0.037 0.002 0.388 0.014

1993-94 0.651 0.1 8.314 1.241 0.036 0.002 0.379 0.013

1994-95 0.685 0.1 8.08 1.196 0.207 0.009 0.365 0.014

1995-96 0.839 0.121 8.022 1.156 0.052 0.002 0.418 0.014

1996-97 0.834 0.119 7.495 1.102 0.154 0.006 0.451 0.013

1997-98 1.026 0.14 0.077 0.003

1998-99 1.193 0.162 0.088 0.003


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significant contrast between the rural and urban populations. On an average the urban population

spends a higher amount. The qualitative and technical changes that have taken place in health

care facilities, infrastructure and manpower were responsible for the development of the Indian

health care sector. The states budgetary allocations encompass declined, as a share of allocations

out of the total revenue budget, which remained reasonably constant in terms of percentage of

the GDP. India spends just about 17.3 percent of total health expenditure on public health. The

annual per capita public health expenditure in the country is no more than Rs. 200 on an average

in 2004.

Health Insurance in India

Introduction

Penetration of health insurance in India is low and is predictable at around 10% of total

population. However, majority of the people insured in India are covered under social health

insurance or community-based health insurance, and the penetration of commercial insurance

may be around 1% only. The reasons for low penetration of commercial health insurance is due

to low level of innovation in health insurance products, exclusions and administrative procedures

governing the policies, and chances of co-variate risks, such as epidemics, which keeps the

premiums high.

Common Observations on Health Insurance Schemes in India

Rural health population is ignorant about health insurance. The majority of the population

is unaware of the Mediclaim and the Jan Arogya Bima policies designed to help the poor.

Only three percent of the population is said to be covered by some form of health

insurance.

Many diseases are excluded from risk coverage (treatment for cataracts, dental care,

sinusitis, tonsillitis, hernia, congenital internal diseases, fistula in anus, piles etc.) in the

first year of the policy, unless such diseases are totally excluded as pre-existing.

Expenses incurred in respect of any treatment relating to pregnancy and childbirth during


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the first 12 weeks of pregnancy is also excluded. Jan Arogya does not cover expenses

related to childbirth and pregnancy. Treatment for asthma, gastro-enteritis, diabetes

mellitus, epilepsy, hypertension, influenza, cough and cold, psychiatric disorders, arthritis

and rheumatism are also excluded from insurance coverage.

The Mediclaim policy is more oriented towards higher income groups and urban people.

Jan Arogya covers only patients who are hospitalized. It is not for out- patients.

There is lack of marketing of insurance schemes. Villagers and the poor have to come to

the headquarters of the district to know about the scheme and to become members.

Officers of the insurance companies have not made any efforts to popularize these

schemes in rural areas and even among the urban poor and middle class people.

Officers of the insurance companies generally say that it is a waste of time and money to

go to people and market the Jan Arogya Bima Policy. They say that it is difficult to

convey to the common man the benefits that flow from these policies. They agree that

they have not taken up comprehensive marketing for popularizing the scheme. Only

business establishments and factories with a large number of employees are approached.

Health insurance policies for the employees of the organized sector viz. Employees State

Insurance Scheme (ESI) and Central Government Health Scheme (CGHS) are highly

subsidized by the government. These schemes operate mainly on the employer’s

contribution. The employee’s contribution accounts for a small portion of the total

coverage.

Health insurance policies are introduced mainly by the public sector.

Health insurance adopted so far (except for employees) is a reimbursement policy. The

individual patient has to pay the hospitals first and then claim a reimbursement and often

there is a long delay in settling the claim.

Brief Description of some Insurance Schemes in India

Social health insurance

The total employment in India today is estimated at 400 million, but of this only 28 million

employees work in organized sector, which is covered by comprehensive social security

legislation, including social health insurance. The largest of this is the ESIS (Employee State


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Insurance Scheme) which covers 8 million employees, and including family members provides

health security to 33 million persons. Some of the state governments have to subsidize the

scheme heavily even though the ESI Corporation, which is the financial arm of the system, has

much surplus funds. All these problems indicate an urgent need for reforms in the ESI scheme

(Vora, 2000)

Another about half per cent of the population is covered through the CGHS (Central Government

Health Scheme). Data of 2002, shows that CGHS spent Rs 2 billion averaging Rs 450 per

beneficiary. While these social insurance plans have been around for a long time, their credibility

is at stake and large scale out-sourcing to the private sector is taking place.

Largely the middle and upper middle classes, about 30 million persons are provided healthcare

protection from employers through reimbursements and/or employer provision. This is estimated

at about Rs 24 billion per year, averaging Rs 3000 per employee per annum. Thus about 10

percent of the country’s population has some form of social insurance cover for health through

their employment.

NGO Health Insurance Schemes in India

Ranson (1999) has reviewed NGO efforts in India in this field. There are some common features

of NGO schemes. The coverage of these schemes varies and most use their own health workers

to provide primary care and have tied up with a hospital to provide secondary care. Premiums are

low, generally fixed and not related to risk. Most schemes have limited coverage and some also

provide wider services besides health and treatment. All these organizations had good track

record of services in the community and then added on health insurance on their existing

activities hence they did not have to establish credibility with the community. The key feature

among them was low premium and low coverage. These NGOs have shown that it is possible to

develop a model of health insurance for the poor without much subsidy. The experience also

suggests that if a credible NGO exists then it is not difficult to develop health insurance as an add

on benefit. What is unclear and need to be researched is that what amount of total health

expenditure does this scheme covers for the poor given that their coverage is limited.


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From time to time, the government has also introduced social security schemes, including health

cover for various groups of population, especially the poor or below poverty line groups, in the

unorganized sector, like the Krishi Shramik Samajik Sanstha Yojana, National Social Assistance

Programme, National Family benefit scheme, National maternity benefit scheme, handloom

workers thrift, health and group insurance, agricultural workers central scheme, janashree bima

yojana, state govt welfare funds, national illness assistance fund and state illness funds etc.

But these schemes are not run on a regular basis that is if a person gets a benefit once there is no

guarantee that the same person continues to get access to that scheme on a regular basis.

Reimbursement and coverage policy in India

There are two major insurance players’ reimbursement and coverage policy and is different from

private and NGO health insurance providers.

For ESIS (Employees State Insurance Scheme)

Depending on ‘allotment’ as per the ESI Act

1. Outpatient medical care at dispensaries or panel clinics.

2. Consultation with specialist and supply of special medicines and tests in addition to outpatient

care.

3. Hospitalization, specialists, drugs and special diet.

4. Cash benefits: Periodical payments to any insured person in case of sickness, pregnancy,

disablement or death resulting from an employment injury.

Note: ESIS does not allow reimbursement of medical treatment outside of allotted facilities. For

example, the Employees State Insurance Act 1948 states that entitlement to medical benefits

does not entitle the insured to ‘claim reimbursement for medical treatment. Except under

regulations’ (Govt. of India, 1999g, p. 50) and ESI (General) Regulations, (Govt. of India,

1999g, p.156)


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For CGHS (Central Government Health Scheme)

1. Consultation and preventive health care service through dispensaries and hospitals under the

scheme.

2. Consultation at a CGHS dispensary / polyclinic or CGHS wing at a recognized hospital.

3. Treatment from a specialist through referral, emergency treatment in private hospitals and

outside India.

4. Reimbursement of consultation fee, for up to four consultations in a total spell of ten days (on

referral)

5. Cost of medicines.

6. Charges for a maximum of ten injections. Reimbursement for specified diseases or ailments.

Health policy and financing decisions in India

The Ministry of Health (MOH) determines National Health care policies, but each of the states

in India is responsible for formulating its own health carePolicies.Policymakers usually looks for

research findings only when they had specific information needs. If the information is not

available internally or through commissioned research outputs, policymakers consult a range of

sources including other ministries and government departments, documents from international

research organizations or national data sets. To a lesser extent, policymakers contact university

departments and national research organizations; however, this channel may be only used if the

University and Policy makers has good established link with the organization. In many cases

consultants were employed to locate relevant published material or to conduct a research study.

The Health ministers majorly make the Health care policies and financial decisions by

themselves, without using research evidence, which actually could help them. Policymakers

don’t see the role that research plays in everyday situations. Senior government officials don’t

appreciate the role of research in Implementing health care programmes as, as they perceive as

an unnecessary expenditure for policy development in resource poor country.


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Furthermore, policy implications that are presented are often too general or unrealistic in terms

of resources. Some policymakers feel that a range of policy recommendations must be provided

for short, medium and long-term strategies and that options should be given for various resource

scenarios and it is important fact that research reports must highlight which agencies should be

responsible for initiating changes.

As communication gap exists in between researchers and policymakers, usually researchers are

unaware of policymakers’ priorities and financial resource constraints and feel difficult to

develop feasible policy recommendations on practicality and affordability of policy

recommendation to policymakers and researchers are not fully aware of political demands and

policies.

A fundamental barrier in India for up taking health research is the absence of a strong evidence

based culture within policy and program development, and a lack of appreciation of the

contribution of research to the policy process, But Slowly evidence based culture is changing in

India, due to the intensive efforts made by Indian council of medical research and National

Health Research priorities are included within its national health plan, the preparation and

funding of new research protocols are based on ENHR identified priorities, which is good news

for development of Health technology Assessment in coming years.

The important public health challenges in India, evidences and

Solutions

Even Indian economy has grown rapidly; the nutritional status of children has remained stunted,

signifying that wide income disparities are preventing the poor from becoming the beneficiaries

of growth. The Reference from revelations of the National Family Health Survey (NFHS-3;

2005-06) are a cause for grave concern as it shows- 45.9 per cent children under 3 years of age

are underweight; 79.1 per cent of children between age 6 and 35 months are anemic, and only

43.5 per cent of children are fully immunized. Maternal anemia remains rampant. Tuberculosis,

malaria and HIV-AIDS are problems still to be overcome. New public health threats are


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emerging in the form of cardiovascular and respiratory diseases, diabetes, cancers, and mental

illness and traffic injuries.

While urbanization and globalization are creating conditions for unhealthy behaviors that

underlie many of these new threats, health transition is affecting rural areas. In 2006,

cardiovascular diseases were found to be the leading cause of death (32 per cent of all deaths).

India is now estimated to have around 120 million persons with hypertension and 40 million with

diabetes — in two decades the numbers are set to reach 215 million and 70 million respectively.

Tobacco claims close to a million lives a year and the World Health Organization (WHO)

projects India as the nation with the most rapidly rising trajectory of tobacco-related deaths over

the next two decades.

The response to these challenges has thus far been limited, in terms of resources mobilized as

well as impact. While the budgetary allocation for health and nutrition programmes has been

dolefully inadequate, even the funds provided were not efficiently utilized owing to the shortage

of appropriately trained human resources for public health delivery, paucity of skilled health

system managers and lack of convergence or connectivity among several vertical programmes.

Despite its pioneering role in championing the concept of universal primary health care, India

has not been able to provide a successful operational model yet but reforms are undergoing,

which will address public health challenges.

Progress was impeded by the lack of appreciation among policy makers of the fact that health

has many social determinants that need inter-disciplinary understanding and multi-sectoral

action. Existing inequities of income, education and access to health services were not

adequately factored into the design and delivery of health programmes, while regional and

gender disparities further undermined their success. It is only recently that the bi-directionality of

health and development has been widely accepted among politicians, health care policy makers

and educated population, even though some disparity exists between different states of India.

Over the next two decades the largest growing segment of our population will be in the age range

of 15 to 59 years. This will provide the nation with a vast reservoir of productive human

resources. Increased investments in health and education are very important if these resources are


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to be protected and promoted for optimal performance. Health also needs to be respected as an

essential and inviolable human right, for fear that the focus on productivity lead to the neglect of

the very young, the elderly and the unemployed is a matter of concern which should be properly

addressed.

Future policies and programmes related to health must, therefore, be guided by a fundamental

and unwavering commitment to the provision of universal health care, which will enable every

citizen to access health-promotive and (disease) preventive, diagnostic, therapeutic and

rehabilitative services. Availability, affordability and accountability along with emphasis on

quality, efficiency and effectiveness must characterize the health services, while equity and

universal outreach must be the pillars on which policy must erect its programmes.

For these objectives to be attained, it will be essential to frame the national health policy with a

clear role-delineation for the various sectors involved (public, voluntary and private), to guide

their individual and collective functions. The public sector has to remain in the front line of

health care, especially with respect to essential preventive and clinical services. The private

sector plays an increasingly important role but its presence is mainly confined to the urban areas.

This accentuates the misdistribution of health services. Health cannot be left mainly to market

forces: global experience teaches us that asymmetry of information and power between provider

and patient leads to serious market failures in health care market. At the same time, the

substantive role of the private sector must be recognized and appropriately regulated.

Quality concerns apply to the public as well as private health sector; hence focus should be on

accreditation. For Example National accreditation Board for Hospitals certification and if

possible JCI accreditation. While inadequate resources and poor motivation often afflict the

former, unethical practices, in pursuit of profit maximization, frequently corrode the latter. The

voluntary sector is committed, but limited in terms of its presence and resources. To achieve

better health outcomes, the public sector must become more responsive, the private sector must

become more responsible, and the voluntary sector must become more resourceful. The blueprint

for the future must optimize the use of each, combining the social dedication of the public sector,


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the altruistic spirit of the truly voluntary sector, and the operational efficiency of the private

sector.

The response should not, however, be limited to policies in the health sector. Policies in other

sectors often blow even more strongly in sectors like health, agriculture, food processing, water

supply, education, environment, rural and urban development are among these list of priorities.

Finance exerts its influence on health, resource allocation, taxes and prices which can be used as

positive motivators for healthy behaviors. Taxes are the most effective interventions to decrease

tobacco consumption and to major extent passing stringent rules on its use in public places.

Policies in all other sectors must become receptive to and supportive of public health priorities.

The promise to raise governmental expenditure on health to 3 per cent of GDP must be quickly

acted upon by central government and state governments also think in same line to support

health care sector development. Convergence of vertical programmes will lead to savings within

the health sector. More resources can be raised from higher taxes on tobacco products, Liquor on

automobiles in cities, and on unhealthy processed foods. Health should not remain in the

silhouette of financial neglect, even as the sun and the Sensex shine on the health of Indian

economy.

Human Resources for Health (HRH) is a critical challenge in Indian health care system . Even as

new-fangled initiatives like the National Rural Health Mission (NRHM) are launched, the

shortage of trained health personnel, in several categories and at multiple levels, becomes

noticeable. A large number of frontline workers from accredited social health activist (ASHA) to

anganwadi workers, from multi-purpose health workers to the person involved in vector control

must stipulate attention to both quantity and quality. The departure of nurses to rewarding

foreign employment and the disinclination of doctors to live in villages accentuate shortages of

Human resource for Health. The health services lack public health expertise to provide the right

technical leadership and managerial expertise to ensure optimal utilization of resources. Limited

capacity for public health-relevant research and weak surveillance systems lead to serious

information gaps, which impede policy and imperil programmes.


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Human resource problems can be redressed. Task Shifting recognizes that nurses can perform

many of the functions reserved for doctors and multi-purpose health workers can perform several

functions performed by nurses. The requisite skill mix can be developed through training and the

roles can be redefined to meet pressing needs. Task Sharing is also desirable to integrate

functions across personnel delivering services covered by numerous vertical programmes, to

reduce redundancy, and to expand collective outreach. More public health professionals must be

trained to assume the leadership of health programmes. Clinical services must be strengthened

through strong referral systems, adequately equipped clinical facilities, and dependable

emergency care countrywide. People them, when empowered, are the best promoters of public

health. Health literacy will appendage them with information, while devolution of resources and

responsibility will enable communities and panchayats to plan, implement, and monitor

programmes efficiently.

Conclusion: Public health must move centre stage from the periphery of development planning,

so that health and economy can nurture each other.

Role of HTA in India

There is no national HTA program in India. Neither the Ministry at the Centre nor at the State

level has adequate in-house capability to design research studies, collate data and analyze

research findings of the various health interventions to enable evidence-based policy-making.

Substantial resources are being spent on programmes and interventions that have a poor evidence

base. For example, there is no evidence to indicate the existing burden of malaria, or maternal

mortality. Similarly, hardly any studies are available to assess the efficacy of the use of a drug or

of a treatment protocol in different settings and conditions for formulating differential strategies

to suit the diverse conditions prevailing in India. The failure to link intervention with evidence

has resulted in poor outcomes.

Research is well-established on a national level, especially essential national Health research

(ENHR), with the Indian Council of Medical Research identifying the priority areas. However,

the main users of these research findings are academics and researchers. In India, for


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commissioned research, there is a direct channel of communication between Health care

researchers and policymakers. For non-commissioned research the channels of dissemination to

policymakers are less clear and more varied, as dissemination of noncommissioned research is

limited to academic channels (e.g. papers in peer-reviewed journals or presentations at

conferences). The direct dissemination of noncommissioned research at central government level

is available to a range of policymakers by distribution of a research report or inviting key

policymakers and other stakeholders to a dissemination workshop often less intensively. Another

Major constraint, policymakers may not fully understand how to use research to support policy

formation as policymakers may not have the ability to evaluate the quality of a research study,

difference between qualitative and quantitative research or to interpret research findings, thus

experience difficulties in incorporating research findings into policy development for health care

programs, which may lead to the failure to translate research into policy or to extraneous

conclusions drawn from research results.

Another key constraint usually health care policy makers face in India is that, research is usually

conducted by the academics or the universities, and Research outputs are mostly presented at

international conferences or published in the international journals and not easily accessible to

policymakers which leads to a gap in utilizing the available research into programming of health

care policy.

Evidence-based decision making is carried out on a very small scale at the national and health

facility levels, with hardly any at the state level. The fact that there is a large private sector on

fee-for service that caters to the more affluent section of the population poses a major challenge.

Much technology, especially sophisticated medical equipment, is acquired by the private

Sector. Efforts have been made to carry out assessments, but these are mostly isolated, with little

dissemination or implementation of recommendations. There is also much clinical and clinical

epidemiological research, for example, by the Indian Clinical Epidemiology Network, but again

suffer from a lack of application of findings.


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Conclusion

Although there was general agreement on the need for HTA in India, this has not been taken

forward, until recently, with renewed efforts being made emphasizing on capacity building.

IDENTIFY PRIORITY DISEASE LIST

In India, we have concept of Integrated Disease Surveillance Project (IDSP), which was

launched by Hon’ble Union Minister of Health & Family Welfare in November 2004. It is a

decentralized, State based Surveillance Program of MOHFW covering the whole country. It is

intended to detect early warning signals of impending outbreaks and help initiate an effective

response in a timely manner. Major components of the project are : (1) Integrating and

decentralization of surveillance activities; (2) Strengthening of public health laboratories; (3)

Human Resource Development – Training of State Surveillance Officers, District Surveillance

Officers, Rapid Response Team, other medical and paramedical staff; and (4) Use of Information

Technology for collection, collation, compilation, analysis and dissemination of data

For Project implementation, Surveillance Units have been set up at Central, State and District

level. Surveillance Committees at National, State and District levels are monitoring the Project.

Currently linkages are being established with all State Head Quarters, District Head Quarters and

all Government Medical Colleges on a Satellite Broadband Hybrid Network enables enhanced

Speedy Data Transfer, Video Conferencing, Discussions, Training e-learning for outbreaks and

program monitoring under IDSP. Video conferencing is being used regularly for discussions

between states and Central Unit during outbreaks and for monitoring if IDSP implementation

and Training. A 24X7 call center with toll free telephone no 1075 accessible from BSNL/MTNL

telephone from all states is in operation since February 2008. This receives disease alerts from

anywhere in the country and shares the information with the respective State/District

Surveillance Units for verification and initiating appropriate actions wherever required. During

the last 10 months of operation, 29,548 calls were received at 1075 during last 10 months of

which 68 were Health Alerts resulting in 7 outbreak alerts.

For formulating Health care policies, it is necessary that we have an evidence-based

understanding of the extent of disease burden, the population groups that are the most vulnerable,


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and what interventions are needed to avert premature death or needless suffering. With the above

objectives in mind, the NCMH(National Council of Medical Health) undertook an exercise to (I)

identify major health conditions in terms of their contribution to India’s disease burden; (ii)

estimate the incidence and prevalence levels of the diseases/conditions at present and in 2015;

(iii) list the causal factors underlying the spread of the diseases/conditions; (iv) suggest, based on

the available evidence, the most cost-effective and low-cost solutions/strategies, both preventive

and curative, for reducing the disease burden, particularly among the poor; and (v) indicate what

interventions should be provided where and by whom.

Methodology

The experts identified 17 priority health conditions (as shown below in Table - 3) which they felt

to be significant public health problems, affecting all segments of the population. Identification

of these conditions was based on three criteria:

first, the likelihood of the burden of a specific health condition falling on the poor, such as

infectious and vector-borne conditions, TB and many maternal and child health conditions;

second, in the absence of interventions, the probability of a listed health condition continuing to

impose a serious health burden on the Indian population in the future, say by 2015, such as

cancers, cardiovascular conditions and diabetes, or new infections such as HIV/AIDS; and

Third, the possibility of a health condition driving a sufficiently large number of people into

financial hardship, including their falling below the poverty line.

In India, where there are limited resources and competing demands, not all conditions can be

treated and not every intervention provided at public expense... The criteria that ought to be used

for identifying such publicly supported interventions. There could be two criteria’s:

• those that are technically effective in substantially ameliorating a major health problem; and

• Those that are financially inexpensive (i.e. cost-effective) relative to the outcome gains

achieved.

The first ensures that the intervention markedly reduces the burden of disease, and does not

simply result in a token improvement in the health status. The second ensures that the


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intervention is good value for money. Thus, policy-makers can focus on several extremely cost-

beneficial and cost-effective interventions that simultaneously yield large gains in outcomes for

several major health conditions.

Table -3 Health conditions and disability-adjusted life-years (DALYs) lost in India, 1998

Share in the

Disease/health condition total burden

Communicable diseases, maternal and DALYs lost

of disease

prenatal conditions ( x 1000)

(%)

Tuberculosis 7,577

2.8

HIV/AIDS 5,611

2.1

Diarrheal diseases 22,005 8.2

Malaria and other vector-borne conditions 4,200 1.6

Leprosy 208 0.1

Childhood diseases 14,463 5.4

Otitis media 475 0.1

Maternal and perinatal conditions 31,207 11.6

Others 49,517 18.4

Non-communicable conditions

Cancers 8,992 3.4

Diabetes 1,981 0.7

Mental illness 22,944 8.5

Blindness 3,699 1.4

Cardiovascular diseases 26,932 10.0

COPD and asthma 4,061 1.5

Oral diseases 1,247 0.5

Others 18,801 7.0

Injuries 45,032 16.7

All listed conditions 200,634 74.6

Others 68,319 25.4 COPD: chronic obstructive pulmonary disease Source: Peters et al. 2001


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Drug Registration Agency in India

-

Figure 4- Showing Hierarchy of drug regulation in India.

.

.

List of Major Drug Regulatory Bodies in India

DCGI: Drugs Controller General of India

DGFT: Directorate-General of Foreign Trade

DBT: Department of Biotechnology

GEAC: Genetic Engineering Approval Committee

RDAC: Recombinant DNA Advisory Committee

IBSC: Institutional Biological Safety Committees

RCGM: Review Committee on Genetic Manipulation

Central Government Drug Statutory Functions

Approve licenses to manufacture certain categories of drug

Regulate Clinical Research in India

Establish regulatory measures, amendments to acts and rules

Screening drug Formulations available in Indian Market

Regulate the standards of imported drugs

Conduct training programs for regulatory officials

Drug Regulation In India

Central Governament Statutory

Functions

State Governments Statuatory Functions


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Approval of new drugs introduced in the country.

Permission to conduct clinical trials - registration and control on the quality of

imported drugs.

Laying down standards for drugs, cosmetics, diagnostics and devices and updating

India Pharmacopoeia.

To approve licenses as the Central License Approving Authority (CLAA) for the

manufacture of large volume parenterals and vaccines and operation of blood banks

and such other drugs as may be notified by the government from time to time.

Coordinating the activities of the States and advising them on matters relating to

uniform administration of the Act and Rules.

State Government Drug Statutory Functions

Licensing of Drug testing labs

Approval of drug formulations for manufacture

Monitoring for quality of drugs and cosmetics, manufactured by respective

states units and those marketed in India

Recall of substandard drugs

Investigation and prosecution in respect to contravention of legal provisions

Pre and Post licensing inspection

Administrative actions

Licensing of drug manufacturing establishments and sales premises.

Carrying out inspections of licensed premises for ensuring compliance to

conditions of licenses.

Drawing samples for test and monitoring the quality of drugs and cosmetics

moving in the State.

Taking appropriate action like suspension cancellation of licenses.

Instituting legal action wherever needed as provided under the D&CA and Rules.


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Drug Registration and Biologics/Pharmaceuticals in India

Drugs are registered with DCGI ( Drug Controller General of India) which is the main regulatory

body -

Drugs & Cosmetics Act & Rules GCP Guidelines, 2001 National Pharmacovigilance Programme, ICMR Guidelines, 2000 (being revised)

Drug registration Procedure in India

India is now a preferred destination for outsourced clinical trials, but is plagued by poor ethical

oversight of the many trial sites and scant information of their existence. The CTRI's vision of

conforming to international requirements for transparency and accountability, but also using trial

registration as a means of improving trial design, conduct and reporting led to the selection of

registry-specific dataset items in addition to those endorsed by the WHO ICTRP. Compliance

with these requirements is good for the trials currently registered, but these trials represent only a

fraction of the trials in progress in India.

Central Drug Standard Control Organization

The main functions of the Central Drug Standard Control Organization (CDSCO) include control

of the quality of drugs imported into the country, co-ordination of the activities of the State/UT

drug control authorities, approval of new drugs proposed to be imported or manufactured in the

country, laying down of regulatory measures and standards of drugs and acting as the Central

Licensing Approving Authority in respect of whole human blood, blood products, large volume

parenterals, sera and vaccines. The CDSCO functions from 4 zonal offices, 3 sub-zonal offices

besides 7 port offices. The four Central Drug Laboratories carry out tests of samples of specific

classes of drugs.

Approval of New Drugs in India

Voluminous literature in relation to Pharmaceutical information, Pharmacology,

Pharmacodynamics, Pharmacokinetic studies, acute and long-term toxicity studies in different


26

species in animals, special toxicity studies including reproductive studies, mutagenicity and

carcinogenicity, clinical trial reports on new drugs for safety, efficacy of a new drug molecule,

are examined before considering grant of permission for clinical trial of new drugs in India. The

clinical trial reports conducted in India are examined including bioavailability studies to establish

bio-equivalence of different brands of a new drug before granting approval for marketing. The

approval of a new drug includes examination of package insert, promotional literature, label

claims, etc. and also testing of the bulk drugs at the Central Drugs Laboratory, Calcutta.

Conclusion

Prospective trial registration is a reality in India. The challenges facing the CTRI include better

engagement with key stakeholders to ensure increased prospective registration of clinical trials

and utilization of existing legislative opportunities to complement these efforts.

Demographic and Socio- Economic Characteristics of India

Total population (thousands), in 2008 - 1181412

Median Age of Population- 24 (2007)

Under 15 (%) – 32 (2007)

Over 60 (%) – 8

Annual growth rate of population (%) (1997-2007) – 1.6

Living in Urban Areas- (%) – 29 (2007)

Based on Civil Coverage Registration – (%)

Births- 41 (2000- 2007)

Death- <25

Life Expectancy –(Male/ Female) : - 63.8/ 66.97

Infant Mortality Rate – Per 1000 – 54 (2007)

Health care Expenditure/ GDP – 5.10% of GDP (2007)


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Expenditure per capita –(USD) –$ 80 (2007)

Health Care Expenditure (%public/private/external) in 2007 –

1) Total expenditure on Health (THE) as % of Gross Domestic Product (GDP)- 5.1

2) Public Expenditure on Health (PHE) as % of Total Expenditure on Health (THE)- 20

3) Private Expenditure on Health (PvtHE) as % of Total Expenditure on Health (THE) -

80

4) EXTERNAL- 1-2%

% out of pocket payments/ total Healthcare Expenditure- 80%

Source: WORLD HEALTH STATISTICS 2009, WHO REPORT- 2009.

Table -4 Demographic Indicators of India

GNI per capita (US$), 2008 1070

Population (thousands), 2008, under 18 446960

Population (thousands), 2008, under 5 126642

Population annual growth rate (%), 1970–1990 2.2

Population annual growth rate (%), 2000–2008 1.6

Crude death rate, 2008 8

Crude birth rate, 2008 23

Life expectancy, 2008 64

Total fertility rate, 2008 2.7

% of population urbanized, 2008 29


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Average annual growth rate of urban population (%), 2000–2008 2.4

Source- WORLD HEALTH STATISTICS 2009, WHO REPORT- 2009

Economic indicators in India

GDP per capita average annual growth rate (%), 1990–2008- 4.7

Average annual rate of inflation (%), 1990–2008 6

% of population below international poverty line of US$1.25 per day, 1992–2007* 42

% of central government expenditure (1998–2007*) allocated to:, health 2

Source: WORLD HEALTH STATISTICS 2009, WHO REPORT- 2009.

References

Peters D, Yazbeck A, Ramana G, Sharma R, Pritchett L, Wagstaff A. Raising the sights: Better

health systems for India’s poor. Washington, DC: The World Bank; 2001.

Ranson MK. (1999) the Consequences of Health Insurance for the Informal Sector: Two Non-

Governmental, Non-Profit Schemes in Gujarat. London School of Hygiene and Tropical

Medicine; Dept. of Public Health and Policy, Health Policy Unit. May 13, 1999.

Satia J, Mavalankar D, Bhat R, Progress and Challenges of Health Sector (1999): A Balance

Sheet, Indian Institute of Management, Ahmedabad October Paper no- 9-10-08.

Vora N. (1999). Employee State Insurance Scheme in Gujarat State. Presentation at One day

workshop on ‘Health Insurance in India’. Indian Institute of Management, Ahmedabad. Oct. 30.


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